Trial Outcomes & Findings for Bay1002670, Fibroids, Safety and Efficacy EU,US,Can, Jap (NCT NCT02131662)
NCT ID: NCT02131662
Last Updated: 2017-12-08
Results Overview
Amenorrhea was defined as no scheduled or unscheduled bleeding/spotting after the end of the initial bleeding episode until end of treatment. Dose-response curve was estimated based on the primary endpoint. The 4 parameters characterizing the dose-response curve were reported in other pre-specified endpoints below.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
309 participants
Primary outcome timeframe
After end of the initial bleeding episode until the end of treatment, up to 12 weeks
Results posted on
2017-12-08
Participant Flow
The study was conducted at multiple centers in 12 countries worldwide between 15 May 2014 (first subject first visit) and 04 May 2016 (last subject last visit).
748 subjects were screened; 439 subjects were not randomized, the majority was screen failures. Therefore, 309 subjects were randomized.
Participant milestones
| Measure |
VPR 4 mg
Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 2 mg
Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 1 mg
Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 0.5 mg
Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
Placebo
Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
62
|
61
|
63
|
62
|
61
|
|
Overall Study
Treated
|
60
|
61
|
61
|
60
|
58
|
|
Overall Study
Completed Treatment
|
57
|
60
|
61
|
56
|
52
|
|
Overall Study
Completed Follow-up
|
54
|
47
|
56
|
42
|
44
|
|
Overall Study
COMPLETED
|
54
|
47
|
56
|
41
|
43
|
|
Overall Study
NOT COMPLETED
|
8
|
14
|
7
|
21
|
18
|
Reasons for withdrawal
| Measure |
VPR 4 mg
Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 2 mg
Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 1 mg
Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 0.5 mg
Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
Placebo
Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
|---|---|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Other
|
2
|
4
|
3
|
3
|
4
|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
1
|
3
|
|
Overall Study
Pregnancy
|
0
|
1
|
0
|
1
|
0
|
|
Overall Study
Wish for pregnancy
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
5
|
1
|
5
|
6
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
0
|
9
|
0
|
|
Overall Study
Not treated
|
2
|
0
|
2
|
2
|
3
|
Baseline Characteristics
Bay1002670, Fibroids, Safety and Efficacy EU,US,Can, Jap
Baseline characteristics by cohort
| Measure |
VPR 4 mg
n=60 Participants
Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 2 mg
n=61 Participants
Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 1 mg
n=61 Participants
Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 0.5 mg
n=60 Participants
Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
Placebo
n=58 Participants
Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
43.5 years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
43 years
STANDARD_DEVIATION 4.6 • n=7 Participants
|
41.9 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
41.7 years
STANDARD_DEVIATION 4.9 • n=4 Participants
|
42.8 years
STANDARD_DEVIATION 5.1 • n=21 Participants
|
42.6 years
STANDARD_DEVIATION 4.7 • n=8 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
58 Participants
n=21 Participants
|
300 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Baseline menstrual blood loss by MP
|
172.3 millilitre(s)
STANDARD_DEVIATION 111.86 • n=5 Participants
|
176.9 millilitre(s)
STANDARD_DEVIATION 128.71 • n=7 Participants
|
178.2 millilitre(s)
STANDARD_DEVIATION 116.64 • n=5 Participants
|
173.6 millilitre(s)
STANDARD_DEVIATION 94.62 • n=4 Participants
|
164.6 millilitre(s)
STANDARD_DEVIATION 78.71 • n=21 Participants
|
173.2 millilitre(s)
STANDARD_DEVIATION 107.21 • n=8 Participants
|
|
Volume of largest fibroid by US
|
78.92 millilitre(s)
STANDARD_DEVIATION 95.644 • n=5 Participants
|
77.66 millilitre(s)
STANDARD_DEVIATION 91.605 • n=7 Participants
|
74.55 millilitre(s)
STANDARD_DEVIATION 88.397 • n=5 Participants
|
81.69 millilitre(s)
STANDARD_DEVIATION 85.62 • n=4 Participants
|
99.03 millilitre(s)
STANDARD_DEVIATION 117.379 • n=21 Participants
|
82.22 millilitre(s)
STANDARD_DEVIATION 95.94 • n=8 Participants
|
PRIMARY outcome
Timeframe: After end of the initial bleeding episode until the end of treatment, up to 12 weeksAmenorrhea was defined as no scheduled or unscheduled bleeding/spotting after the end of the initial bleeding episode until end of treatment. Dose-response curve was estimated based on the primary endpoint. The 4 parameters characterizing the dose-response curve were reported in other pre-specified endpoints below.
Outcome measures
| Measure |
VPR 4 mg
n=60 Participants
Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 2 mg
n=61 Participants
Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 1 mg
n=61 Participants
Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 0.5 mg
n=60 Participants
Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
Placebo
n=58 Participants
Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
|---|---|---|---|---|---|
|
Percentage of Subjects With Amenorrhea, Defined as no Scheduled or Unscheduled Bleeding/Spotting After the End of the Initial Bleeding Episode Until End of Treatment
|
60 Percentage of subjects
|
54.1 Percentage of subjects
|
55.7 Percentage of subjects
|
30 Percentage of subjects
|
1.7 Percentage of subjects
|
SECONDARY outcome
Timeframe: From baseline to end of follow-upIn the below table, "N" signifies subjects who were evaluable for the specific parameter at that timepoint for each arm, respectively.
Outcome measures
| Measure |
VPR 4 mg
n=60 Participants
Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 2 mg
n=61 Participants
Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 1 mg
n=61 Participants
Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 0.5 mg
n=60 Participants
Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
Placebo
n=58 Participants
Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
|---|---|---|---|---|---|
|
Change in Volume of Menstrual Blood Loss Per 28 Days From Baseline During Treatment by Reference Period (Assessed by Alkaline Hematin Method)
1st period (N=46, 46, 47, 45, 45)
|
-79.83 mL
Standard Deviation 234.22 • Interval 234.22 to
|
-30.18 mL
Standard Deviation 106.82 • Interval 106.82 to
|
-55.42 mL
Standard Deviation 109.29 • Interval 109.29 to
|
-44.14 mL
Standard Deviation 110.61 • Interval 110.61 to
|
17.22 mL
Standard Deviation 124.14 • Interval 124.14 to
|
|
Change in Volume of Menstrual Blood Loss Per 28 Days From Baseline During Treatment by Reference Period (Assessed by Alkaline Hematin Method)
2ndperiod (N=44, 45, 47, 44, 44)
|
-203.43 mL
Standard Deviation 215.23 • Interval 215.23 to
|
-166.71 mL
Standard Deviation 149.57 • Interval 149.57 to
|
-181.76 mL
Standard Deviation 111.98 • Interval 111.98 to
|
-146.32 mL
Standard Deviation 136.97 • Interval 136.97 to
|
-28.42 mL
Standard Deviation 113.93 • Interval 113.93 to
|
|
Change in Volume of Menstrual Blood Loss Per 28 Days From Baseline During Treatment by Reference Period (Assessed by Alkaline Hematin Method)
3rd period (N=43, 45, 47, 43, 40)
|
-205.08 mL
Standard Deviation 214.8 • Interval 214.8 to
|
-173.38 mL
Standard Deviation 153.37 • Interval 153.37 to
|
-185.77 mL
Standard Deviation 106.91 • Interval 106.91 to
|
-147.55 mL
Standard Deviation 138.4 • Interval 138.4 to
|
-36.69 mL
Standard Deviation 117.98 • Interval 117.98 to
|
SECONDARY outcome
Timeframe: During treatment periodOnset of controlled bleeding was defined by the first day, for which the MBL (assessed by MP, Version 2014) for all subsequent 28-day periods up to the end of the treatment period was less than 80 mL. Kaplan-Meier estimated time to onset of controlled bleeding (days) was reported.
Outcome measures
| Measure |
VPR 4 mg
n=60 Participants
Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 2 mg
n=61 Participants
Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 1 mg
n=59 Participants
Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 0.5 mg
n=53 Participants
Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
Placebo
n=26 Participants
Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
|---|---|---|---|---|---|
|
Time to Onset of Controlled Bleeding
|
2 Days
Interval 1.0 to 3.0
|
2 Days
Interval 1.0 to 3.0
|
3 Days
Interval 1.0 to 3.0
|
2 Days
Interval 1.0 to 4.0
|
NA Days
Interval 32.0 to
insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From baseline to end of follow-up periodPelvic Magnetic resonance imagings (MRI), without contrast agents, were performed for volume measurements of the uterus and fibroids preferably using 1.5 Tesla scanners or higher. Images were sent to the imaging core laboratory for evaluation. Volume measurements of the uterus and fibroids were performed centrally by independent radiologist(s).
Outcome measures
| Measure |
VPR 4 mg
n=60 Participants
Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 2 mg
n=61 Participants
Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 1 mg
n=61 Participants
Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 0.5 mg
n=60 Participants
Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
Placebo
n=58 Participants
Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
|---|---|---|---|---|---|
|
Change in Volume of Largest Fibroid Compared to Baseline Measured by MRI
End of treatment (N=47, 52, 58, 47, 48)
|
-41.4 mL
Interval -98.0 to 10.0
|
-27.2 mL
Interval -81.0 to 47.0
|
-18.9 mL
Interval -85.0 to 11314.0
|
-14.9 mL
Interval -68.0 to 74.0
|
4.9 mL
Interval -67.0 to 271.0
|
|
Change in Volume of Largest Fibroid Compared to Baseline Measured by MRI
Follow-up (N=45, 48, 55, 40, 41)
|
-26.9 mL
Interval -94.0 to 18.0
|
-15 mL
Interval -82.0 to 52.0
|
-9.7 mL
Interval -79.0 to 437.0
|
-9.3 mL
Interval -96.0 to 91.0
|
5.1 mL
Interval -59.0 to 364.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From start of the study treatment to Day 84 (treatment period)Population: The exposure response analysis includes all verum treated subjects with valid PK concentration data and valid PD data and all placebo treated subjects with valid PD data (placebo: 50, 0.5 mg 50, 1.0 mg 56, 2.0 mg: 56, 4.0 mg: 55, in total 267).
Maximum effect of vilaprisan on induced amenorrhea during treatment period. Induced amenorrhea was defined as number of subjects with amenorrhea (that is, all days with bleeding intensity 1 = none) , i.e. no bleeding or spotting allowed after initial bleeding episode until end of treatment. The nature of this exposure response analysis was the development of a model valid for the exposure response relationship over the entire range of available exposures (i.e. across all dose groups). Therefore, observations (exposure - induced amenorrhea) of all subjects need to be combined.
Outcome measures
| Measure |
VPR 4 mg
n=267 Participants
Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 2 mg
Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 1 mg
Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 0.5 mg
Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
Placebo
Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
|---|---|---|---|---|---|
|
Exposure-response Analysis of Vilaprisan - Percentage of Subjects Achieving Maximum Effect (Emax) of Induced Amenorrhea
|
59 Percentage of subjects
Interval 49.0 to 68.0
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From start of the study treatment to Day 84 (treatment period)Population: The exposure response analysis includes all verum treated subjects with valid PK concentration data and valid PD data and all placebo treated subjects with valid PD data (placebo: 50, 0.5 mg 50, 1.0 mg 56, 2.0 mg: 56, 4.0 mg: 55, in total 267).
Area-under-the-curve (AUC) of vilaprisan between 0 and 24 hours post-dose at steady-state achieving 50% of maximum effect of vilaprisan on induced amenorrhea during treatment period. Induced amenorrhea was defined as number of subjects with induced-amenorrhea (that is, all days with bleeding intensity 1 = none) , i.e. no bleeding or spotting allowed after initial bleeding episode until end of treatment. The nature of this exposure response analysis was the development of a model valid for the exposure response relationship over the entire range of available exposures (i.e. across all dose groups). Therefore, observations (exposure - induced amenorrhea) of all subjects need to be combined.
Outcome measures
| Measure |
VPR 4 mg
n=267 Participants
Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 2 mg
Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 1 mg
Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 0.5 mg
Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
Placebo
Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
|---|---|---|---|---|---|
|
Steady-state Exposure Achieving Half-maximal Effect (EAUC50) of Induced Amenorrhea During Treatment Period of Vilaprisan
|
36.93 mcg*h/L
Interval 27.69 to 48.69
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From start of the study treatment to Day 84 (treatment period)The final exposure-response model was used to simulate the percentage of subjects below 90% of the maximum probability of induced amenorrhea (that is, all days with bleeding intensity 1 = none) for the selected doses 1, 2 and 3 mg (see table below).
Outcome measures
| Measure |
VPR 4 mg
n=267 Participants
Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 2 mg
Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 1 mg
Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 0.5 mg
Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
Placebo
Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
|---|---|---|---|---|---|
|
Exposure-response Analysis of Vilaprisan - Predicted Percentage of Subjects Below 90% of the Maximum Probability of Induced Amenorrhea
1 mg
|
36 Percentage of subjects
|
—
|
—
|
—
|
—
|
|
Exposure-response Analysis of Vilaprisan - Predicted Percentage of Subjects Below 90% of the Maximum Probability of Induced Amenorrhea
2 mg
|
2 Percentage of subjects
|
—
|
—
|
—
|
—
|
|
Exposure-response Analysis of Vilaprisan - Predicted Percentage of Subjects Below 90% of the Maximum Probability of Induced Amenorrhea
3 mg
|
1 Percentage of subjects
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At baselinePopulation: An analysis set for the assessment of the interchangeability of the MP and the AH method to judge MBL included all screened subjects (except subjects in Japan) with any sanitary product data for which there is any matching pair of MP score and AH value available. A total of 399 subjects were included in this analysis set.
The ability of the MP to identify subjects with HMB (defined as \> 80 mL of blood loss during bleeding episode) per 28 days against the the current gold standard (i.e. AH method) was assessed. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of MP method for detecting heavy menstrual bleeding were calculated against AH method. Sensitivity = true positive/(true positive + false negative)\*100; Specificity = true negative/(true negative + false positive)\*100; PPV = true positive/(true positive + false positive)\*100; NPV = true negative/(true negative + false negative)\*100. MP version 2014 was originally defined based on studies in healthy subjects. And MP version 2016 was developed for study population of women with heavy bleeding.
Outcome measures
| Measure |
VPR 4 mg
n=399 Participants
Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 2 mg
Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 1 mg
Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 0.5 mg
Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
Placebo
Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
|---|---|---|---|---|---|
|
Assessment of MP to Identify Subjects With Heavy Menstrual Bleeding (HMB)
Version 2014: Sensitivity
|
83.3 Percentage
|
—
|
—
|
—
|
—
|
|
Assessment of MP to Identify Subjects With Heavy Menstrual Bleeding (HMB)
Version 2014: Specificity
|
77.3 Percentage
|
—
|
—
|
—
|
—
|
|
Assessment of MP to Identify Subjects With Heavy Menstrual Bleeding (HMB)
Version 2014: PPV
|
82.1 Percentage
|
—
|
—
|
—
|
—
|
|
Assessment of MP to Identify Subjects With Heavy Menstrual Bleeding (HMB)
Version 2014: NPV
|
78.7 Percentage
|
—
|
—
|
—
|
—
|
|
Assessment of MP to Identify Subjects With Heavy Menstrual Bleeding (HMB)
Version 2016: Sensitivity
|
89.7 Percentage
|
—
|
—
|
—
|
—
|
|
Assessment of MP to Identify Subjects With Heavy Menstrual Bleeding (HMB)
Version 2016: Specificity
|
54.5 Percentage
|
—
|
—
|
—
|
—
|
|
Assessment of MP to Identify Subjects With Heavy Menstrual Bleeding (HMB)
Version 2016: PPV
|
70.6 Percentage
|
—
|
—
|
—
|
—
|
|
Assessment of MP to Identify Subjects With Heavy Menstrual Bleeding (HMB)
Version 2016: NPV
|
81.4 Percentage
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Last 28 Days of TreatmentOutcome measures
| Measure |
VPR 4 mg
n=60 Participants
Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 2 mg
n=61 Participants
Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 1 mg
n=61 Participants
Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 0.5 mg
n=60 Participants
Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
Placebo
n=58 Participants
Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
|---|---|---|---|---|---|
|
Percentage of Subjects With Amenorrhea (Defined as MBL < 2 mL) During the Last 28 Days of Treatment
|
83.33 Percentage of subjects
|
88.52 Percentage of subjects
|
85.25 Percentage of subjects
|
65 Percentage of subjects
|
8.62 Percentage of subjects
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Last 28 Days of TreatmentOutcome measures
| Measure |
VPR 4 mg
n=60 Participants
Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 2 mg
n=61 Participants
Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 1 mg
n=61 Participants
Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 0.5 mg
n=60 Participants
Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
Placebo
n=58 Participants
Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
|---|---|---|---|---|---|
|
Percentage of Subjects With HMB Response During the Last 28 Days of Treatment
|
93.33 Percentage of subjects
|
96.72 Percentage of subjects
|
93.44 Percentage of subjects
|
81.67 Percentage of subjects
|
29.31 Percentage of subjects
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After end of the initial bleeding episode until the end of treatmentThe primary objective was to estimate the dose-response curve based on the primary endpoint: subjects with amenorrhea. The number of subjects with amenorrhea was assumed to be binomial distributed. A 4 parameters logistic model was used to fit the observed data for characterizing the dose-response curve: E0, Emax, ED50 and δ. The model is defined as p(d)=E0 + Emax/{1+ e\^\[{ED50-d)/δ\]}. E0 is the amenorrhea rate for placebo; Emax is the maximum effect attributable to the drug (compared with the basal effect with dose at d=0 \[placebo group\], the maximum increase of drug effect).
Outcome measures
| Measure |
VPR 4 mg
n=300 Participants
Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 2 mg
Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 1 mg
Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 0.5 mg
Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
Placebo
Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
|---|---|---|---|---|---|
|
Estimated Dose-response Curve Based on Amenorrhea - E0 and Emax
E0
|
0.82 Percentage
|
—
|
—
|
—
|
—
|
|
Estimated Dose-response Curve Based on Amenorrhea - E0 and Emax
Emax
|
57 Percentage
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After end of the initial bleeding episode until the end of treatmentThe primary objective was to estimate the dose-response curve based on the primary endpoint: subjects with amenorrhea. The number of subjects with amenorrhea was assumed to be binomial distributed. A 4 parameters logistic model was used to fit the observed data for characterizing the dose-response curve: E0, Emax, ED50 and δ. The model is defined as p(d)=E0 + Emax/{1+ e\^\[{ED50-d)/δ\]}. ED50 is the dose at which 50% of Emax were achieved.
Outcome measures
| Measure |
VPR 4 mg
n=300 Participants
Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 2 mg
Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 1 mg
Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 0.5 mg
Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
Placebo
Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
|---|---|---|---|---|---|
|
Estimated Dose-response Curve Based on Amenorrhea - ED50
|
0.5 mg
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: After end of the initial bleeding episode until the end of treatmentThe primary objective was to estimate the dose-response curve based on the primary endpoint: subjects with amenorrhea. The number of subjects with amenorrhea was assumed to be binomial distributed. A 4 parameters logistic model was used to fit the observed data for characterizing the dose-response curve: E0, Emax, ED50 and δ. The model is defined as p(d)=E0 + Emax/{1+ e\^\[{ED50-d)/δ\]}. δ is hill slope parameter which measures sensitivity of the response to the dose range of the drug, determining the steepness of the dose-response curve.
Outcome measures
| Measure |
VPR 4 mg
n=300 Participants
Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 2 mg
Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 1 mg
Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 0.5 mg
Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
Placebo
Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
|---|---|---|---|---|---|
|
Estimated Dose-response Curve Based on Amenorrhea - δ
|
0.145 Slope
|
—
|
—
|
—
|
—
|
Adverse Events
VPR 4 mg
Serious events: 2 serious events
Other events: 31 other events
Deaths: 0 deaths
VPR 2 mg
Serious events: 4 serious events
Other events: 30 other events
Deaths: 0 deaths
VPR 1 mg
Serious events: 3 serious events
Other events: 31 other events
Deaths: 0 deaths
VPR 0.5 mg
Serious events: 2 serious events
Other events: 32 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VPR 4 mg
n=60 participants at risk
Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 2 mg
n=61 participants at risk
Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 1 mg
n=61 participants at risk
Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 0.5 mg
n=60 participants at risk
Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
Placebo
n=58 participants at risk
Subjects matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/60 • From start of study treatment until the end of the 6-month follow-up period
|
1.6%
1/61 • Number of events 1 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/61 • From start of study treatment until the end of the 6-month follow-up period
|
1.7%
1/60 • Number of events 1 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/58 • From start of study treatment until the end of the 6-month follow-up period
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/60 • From start of study treatment until the end of the 6-month follow-up period
|
1.6%
1/61 • Number of events 1 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/61 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/60 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/58 • From start of study treatment until the end of the 6-month follow-up period
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/60 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/61 • From start of study treatment until the end of the 6-month follow-up period
|
1.6%
1/61 • Number of events 1 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/60 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/58 • From start of study treatment until the end of the 6-month follow-up period
|
|
Infections and infestations
Pneumonia
|
0.00%
0/60 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/61 • From start of study treatment until the end of the 6-month follow-up period
|
1.6%
1/61 • Number of events 1 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/60 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/58 • From start of study treatment until the end of the 6-month follow-up period
|
|
Investigations
Alanine aminotransferase increased
|
1.7%
1/60 • Number of events 1 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/61 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/61 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/60 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/58 • From start of study treatment until the end of the 6-month follow-up period
|
|
Investigations
Aspartate aminotransferase increased
|
1.7%
1/60 • Number of events 1 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/61 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/61 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/60 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/58 • From start of study treatment until the end of the 6-month follow-up period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
1.7%
1/60 • Number of events 1 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/61 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/61 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/60 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/58 • From start of study treatment until the end of the 6-month follow-up period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to ovary
|
0.00%
0/60 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/61 • From start of study treatment until the end of the 6-month follow-up period
|
1.6%
1/61 • Number of events 1 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/60 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/58 • From start of study treatment until the end of the 6-month follow-up period
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/60 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/61 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/61 • From start of study treatment until the end of the 6-month follow-up period
|
1.7%
1/60 • Number of events 1 • From start of study treatment until the end of the 6-month follow-up period
|
1.7%
1/58 • Number of events 1 • From start of study treatment until the end of the 6-month follow-up period
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous complete
|
0.00%
0/60 • From start of study treatment until the end of the 6-month follow-up period
|
1.6%
1/61 • Number of events 1 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/61 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/60 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/58 • From start of study treatment until the end of the 6-month follow-up period
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/60 • From start of study treatment until the end of the 6-month follow-up period
|
1.6%
1/61 • Number of events 1 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/61 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/60 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/58 • From start of study treatment until the end of the 6-month follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/60 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/61 • From start of study treatment until the end of the 6-month follow-up period
|
1.6%
1/61 • Number of events 1 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/60 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/58 • From start of study treatment until the end of the 6-month follow-up period
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/60 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/61 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/61 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/60 • From start of study treatment until the end of the 6-month follow-up period
|
1.7%
1/58 • Number of events 1 • From start of study treatment until the end of the 6-month follow-up period
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/60 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/61 • From start of study treatment until the end of the 6-month follow-up period
|
1.6%
1/61 • Number of events 1 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/60 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/58 • From start of study treatment until the end of the 6-month follow-up period
|
Other adverse events
| Measure |
VPR 4 mg
n=60 participants at risk
Subjects received 4 milligram (mg) VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 2 mg
n=61 participants at risk
Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 1 mg
n=61 participants at risk
Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
VPR 0.5 mg
n=60 participants at risk
Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
Placebo
n=58 participants at risk
Subjects matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.0%
3/60 • Number of events 3 • From start of study treatment until the end of the 6-month follow-up period
|
4.9%
3/61 • Number of events 3 • From start of study treatment until the end of the 6-month follow-up period
|
4.9%
3/61 • Number of events 4 • From start of study treatment until the end of the 6-month follow-up period
|
3.3%
2/60 • Number of events 2 • From start of study treatment until the end of the 6-month follow-up period
|
8.6%
5/58 • Number of events 5 • From start of study treatment until the end of the 6-month follow-up period
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
4/60 • Number of events 9 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/61 • From start of study treatment until the end of the 6-month follow-up period
|
1.6%
1/61 • Number of events 1 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/60 • From start of study treatment until the end of the 6-month follow-up period
|
5.2%
3/58 • Number of events 3 • From start of study treatment until the end of the 6-month follow-up period
|
|
Gastrointestinal disorders
Nausea
|
5.0%
3/60 • Number of events 4 • From start of study treatment until the end of the 6-month follow-up period
|
4.9%
3/61 • Number of events 3 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/61 • From start of study treatment until the end of the 6-month follow-up period
|
3.3%
2/60 • Number of events 2 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/58 • From start of study treatment until the end of the 6-month follow-up period
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/60 • From start of study treatment until the end of the 6-month follow-up period
|
1.6%
1/61 • Number of events 1 • From start of study treatment until the end of the 6-month follow-up period
|
1.6%
1/61 • Number of events 2 • From start of study treatment until the end of the 6-month follow-up period
|
5.0%
3/60 • Number of events 3 • From start of study treatment until the end of the 6-month follow-up period
|
3.4%
2/58 • Number of events 2 • From start of study treatment until the end of the 6-month follow-up period
|
|
Infections and infestations
Nasopharyngitis
|
5.0%
3/60 • Number of events 5 • From start of study treatment until the end of the 6-month follow-up period
|
1.6%
1/61 • Number of events 1 • From start of study treatment until the end of the 6-month follow-up period
|
3.3%
2/61 • Number of events 2 • From start of study treatment until the end of the 6-month follow-up period
|
6.7%
4/60 • Number of events 4 • From start of study treatment until the end of the 6-month follow-up period
|
12.1%
7/58 • Number of events 7 • From start of study treatment until the end of the 6-month follow-up period
|
|
Infections and infestations
Urinary tract infection
|
5.0%
3/60 • Number of events 3 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/61 • From start of study treatment until the end of the 6-month follow-up period
|
1.6%
1/61 • Number of events 1 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/60 • From start of study treatment until the end of the 6-month follow-up period
|
5.2%
3/58 • Number of events 3 • From start of study treatment until the end of the 6-month follow-up period
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
5.0%
3/60 • Number of events 3 • From start of study treatment until the end of the 6-month follow-up period
|
1.6%
1/61 • Number of events 1 • From start of study treatment until the end of the 6-month follow-up period
|
6.6%
4/61 • Number of events 4 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/60 • From start of study treatment until the end of the 6-month follow-up period
|
1.7%
1/58 • Number of events 1 • From start of study treatment until the end of the 6-month follow-up period
|
|
Investigations
Weight increased
|
6.7%
4/60 • Number of events 4 • From start of study treatment until the end of the 6-month follow-up period
|
1.6%
1/61 • Number of events 1 • From start of study treatment until the end of the 6-month follow-up period
|
1.6%
1/61 • Number of events 1 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/60 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/58 • From start of study treatment until the end of the 6-month follow-up period
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
4/60 • Number of events 6 • From start of study treatment until the end of the 6-month follow-up period
|
6.6%
4/61 • Number of events 4 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/61 • From start of study treatment until the end of the 6-month follow-up period
|
3.3%
2/60 • Number of events 2 • From start of study treatment until the end of the 6-month follow-up period
|
3.4%
2/58 • Number of events 2 • From start of study treatment until the end of the 6-month follow-up period
|
|
Nervous system disorders
Dizziness
|
5.0%
3/60 • Number of events 5 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/61 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/61 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/60 • From start of study treatment until the end of the 6-month follow-up period
|
1.7%
1/58 • Number of events 1 • From start of study treatment until the end of the 6-month follow-up period
|
|
Nervous system disorders
Headache
|
8.3%
5/60 • Number of events 8 • From start of study treatment until the end of the 6-month follow-up period
|
8.2%
5/61 • Number of events 6 • From start of study treatment until the end of the 6-month follow-up period
|
11.5%
7/61 • Number of events 13 • From start of study treatment until the end of the 6-month follow-up period
|
8.3%
5/60 • Number of events 9 • From start of study treatment until the end of the 6-month follow-up period
|
12.1%
7/58 • Number of events 11 • From start of study treatment until the end of the 6-month follow-up period
|
|
Psychiatric disorders
Insomnia
|
5.0%
3/60 • Number of events 3 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/61 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/61 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/60 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/58 • From start of study treatment until the end of the 6-month follow-up period
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
3.3%
2/60 • Number of events 2 • From start of study treatment until the end of the 6-month follow-up period
|
3.3%
2/61 • Number of events 2 • From start of study treatment until the end of the 6-month follow-up period
|
1.6%
1/61 • Number of events 1 • From start of study treatment until the end of the 6-month follow-up period
|
6.7%
4/60 • Number of events 5 • From start of study treatment until the end of the 6-month follow-up period
|
1.7%
1/58 • Number of events 1 • From start of study treatment until the end of the 6-month follow-up period
|
|
Reproductive system and breast disorders
Menorrhagia
|
3.3%
2/60 • Number of events 3 • From start of study treatment until the end of the 6-month follow-up period
|
6.6%
4/61 • Number of events 6 • From start of study treatment until the end of the 6-month follow-up period
|
9.8%
6/61 • Number of events 6 • From start of study treatment until the end of the 6-month follow-up period
|
5.0%
3/60 • Number of events 4 • From start of study treatment until the end of the 6-month follow-up period
|
6.9%
4/58 • Number of events 6 • From start of study treatment until the end of the 6-month follow-up period
|
|
Reproductive system and breast disorders
Metrorrhagia
|
8.3%
5/60 • Number of events 7 • From start of study treatment until the end of the 6-month follow-up period
|
11.5%
7/61 • Number of events 17 • From start of study treatment until the end of the 6-month follow-up period
|
11.5%
7/61 • Number of events 10 • From start of study treatment until the end of the 6-month follow-up period
|
6.7%
4/60 • Number of events 5 • From start of study treatment until the end of the 6-month follow-up period
|
1.7%
1/58 • Number of events 1 • From start of study treatment until the end of the 6-month follow-up period
|
|
Reproductive system and breast disorders
Ovarian cyst
|
6.7%
4/60 • Number of events 5 • From start of study treatment until the end of the 6-month follow-up period
|
8.2%
5/61 • Number of events 5 • From start of study treatment until the end of the 6-month follow-up period
|
6.6%
4/61 • Number of events 6 • From start of study treatment until the end of the 6-month follow-up period
|
25.0%
15/60 • Number of events 16 • From start of study treatment until the end of the 6-month follow-up period
|
8.6%
5/58 • Number of events 7 • From start of study treatment until the end of the 6-month follow-up period
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.0%
3/60 • Number of events 3 • From start of study treatment until the end of the 6-month follow-up period
|
1.6%
1/61 • Number of events 1 • From start of study treatment until the end of the 6-month follow-up period
|
3.3%
2/61 • Number of events 4 • From start of study treatment until the end of the 6-month follow-up period
|
1.7%
1/60 • Number of events 1 • From start of study treatment until the end of the 6-month follow-up period
|
0.00%
0/58 • From start of study treatment until the end of the 6-month follow-up period
|
|
Vascular disorders
Hot flush
|
13.3%
8/60 • Number of events 8 • From start of study treatment until the end of the 6-month follow-up period
|
8.2%
5/61 • Number of events 5 • From start of study treatment until the end of the 6-month follow-up period
|
8.2%
5/61 • Number of events 6 • From start of study treatment until the end of the 6-month follow-up period
|
10.0%
6/60 • Number of events 8 • From start of study treatment until the end of the 6-month follow-up period
|
6.9%
4/58 • Number of events 4 • From start of study treatment until the end of the 6-month follow-up period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60